Faculty of Health Sciences, University of Southampton, Southampton, UK.
c/o Cochrane Incontinence, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.
Cochrane Database Syst Rev. 2021 Oct 26;10(10):CD006008. doi: 10.1002/14651858.CD006008.pub5.
Intermittent catheterisation (IC) is a commonly recommended procedure for people with incomplete bladder emptying. Frequent complications are urinary tract infection (UTI), urethral trauma and discomfort during catheter use. Despite the many designs of intermittent catheter, including different lengths, materials and coatings, it is unclear which catheter techniques, strategies or designs affect the incidence of UTI and other complications, measures of satisfaction/quality of life and cost-effectiveness. This is an update of a Cochrane Review first published in 2007. OBJECTIVES: To assess the clinical and cost-effectiveness of different catheterisation techniques, strategies and catheter designs, and their impact, on UTI and other complications, and measures of satisfaction/quality of life among adults and children whose long-term bladder condition is managed by intermittent catheterisation.
We searched the Cochrane Incontinence Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 12 April 2021), the reference lists of relevant articles and conference proceedings, and we attempted to contact other investigators for unpublished data or for clarification.
Randomised controlled trials (RCTs) or randomised cross-over trials comparing at least two different catheterisation techniques, strategies or catheter designs.
As per standard Cochrane methodological procedures, two review authors independently extracted data, assessed risk of bias and assessed the certainty of evidence using GRADE. Outcomes included the number of people with symptomatic urinary tract infections, complications such as urethral trauma/bleeding, comfort and ease of use of catheters, participant satisfaction and preference, quality of life measures and economic outcomes.
We included 23 trials (1339 randomised participants), including twelve RCTs and eleven cross-over trials. Most were small (fewer than 60 participants completed), although three trials had more than 100 participants. Length of follow-up ranged from one month to 12 months and there was considerable variation in definitions of UTI. Most of the data from cross-over trials were not presented in a useable form for this review. Risk of bias was unclear in many domains due to insufficient information in the trial reports and several trials were judged to have a high risk of performance bias due to lack of blinding and a high risk of attrition bias. The certainty of evidence was downgraded for risk of bias, and imprecision due to low numbers of participants. Aseptic versus clean technique We are uncertain if there is any difference between aseptic and clean techniques in the risk of symptomatic UTI because the evidence is low-certainty and the 95% confidence interval (CI) is consistent with possible benefit and possible harm (RR 1.20 95% CI 0.54 to 2.66; one study; 36 participants). We identified no data relating to the risk of adverse events comparing aseptic and clean techniques or participant satisfaction or preference. Single-use (sterile) catheter versus multiple-use (clean) We are uncertain if there is any difference between single-use and multiple-use catheters in terms of the risk of symptomatic UTI because the certainty of evidence is low and the 95% CI is consistent with possible benefit and possible harm (RR 0.98, 95% CI 0.55, 1.74; two studies; 97 participants). One study comparing single-use catheters to multiple-use catheters reported zero adverse events in either group; no other adverse event data were reported for this comparison. We identified no data for participant satisfaction or preference. Hydrophilic-coated catheters versus uncoated catheters We are uncertain if there is any difference between hydrophilic and uncoated catheters in terms of the number of people with symptomatic UTI because the certainty of evidence is low and the 95% CI is consistent with possible benefit and possible harm (RR 0.89, 95% CI 0.69 to 1.14; two studies; 98 participants). Uncoated catheters probably slightly reduce the risk of urethral trauma and bleeding compared to hydrophilic-coated catheters (RR 1.37, 95% CI 1.01 to 1.87; moderate-certainty evidence). The evidence is uncertain if hydrophilic-coated catheters compared with uncoated catheters has any effect on participant satisfaction measured on a 0-10 scale (MD 0.7 higher, 95% CI 0.19 to 1.21; very low-certainty evidence; one study; 114 participants). Due to the paucity of data, we could not assess the certainty of evidence relating to participant preference (one cross-over trial of 29 participants reported greater preference for a hydrophilic-coated catheter (19/29) compared to an uncoated catheter (10/29)). AUTHORS' CONCLUSIONS: Despite a total of 23 trials, the paucity of useable data and uncertainty of the evidence means that it remains unclear whether the incidence of UTI or other complications is affected by use of aseptic or clean technique, single (sterile) or multiple-use (clean) catheters, coated or uncoated catheters or different catheter lengths. The current research evidence is uncertain and design and reporting issues are significant. More well-designed trials are needed. Such trials should include analysis of cost-effectiveness because there are likely to be substantial differences associated with the use of different catheterisation techniques and strategies, and catheter designs.
间歇性导尿(IC)是一种常用于治疗不完全排空膀胱的常用方法。常见的并发症有尿路感染(UTI)、尿道创伤和导尿时的不适。尽管有许多不同设计的间歇性导尿管,包括不同的长度、材料和涂层,但目前尚不清楚哪种导尿管技术、策略或设计会影响 UTI 和其他并发症的发生率,以及对满意度/生活质量的影响和成本效益。这是一篇发表于 2007 年的 Cochrane 综述的更新。
评估不同导尿技术、策略和导管设计在成人和儿童长期膀胱状况管理中通过间歇性导尿治疗的情况下,对 UTI 和其他并发症以及满意度/生活质量的影响。
我们检索了 Cochrane 尿控专题注册库,其中包含从 Cochrane 中心对照试验注册库(CENTRAL)、MEDLINE、MEDLINE 正在处理、MEDLINE 提前在线出版、CINAHL、ClinicalTrials.gov、WHO ICTRP 和期刊会议记录(2021 年 4 月 12 日检索)手动搜索中确定的试验,以及相关文章和会议记录的参考文献列表,并尝试联系其他研究人员以获取未发表的数据或澄清信息。
比较至少两种不同导尿技术、策略或导管设计的随机对照试验(RCT)或随机交叉试验。
按照标准的 Cochrane 方法学程序,两名综述作者独立提取数据、评估风险偏倚,并使用 GRADE 评估证据的确定性。结局包括有症状尿路感染的人数、尿道创伤/出血等并发症、导管的舒适度和易用性、参与者的满意度和偏好、生活质量测量和经济结局。
我们纳入了 23 项试验(1339 名随机参与者),包括 12 项 RCT 和 11 项交叉试验。大多数试验规模较小(少于 60 名参与者完成),尽管有 3 项试验有超过 100 名参与者。随访时间从一个月到 12 个月不等,尿路感染的定义也有很大差异。大多数交叉试验的数据由于试验报告中信息不足,无法用于本综述。由于缺乏盲法和高失访偏倚风险,许多交叉试验的数据都没有以可用的形式呈现。由于参与者数量少,风险偏倚和不精确性导致证据确定性被降级。
我们不确定无菌技术与清洁技术相比,在有症状的 UTI 风险方面是否有差异,因为证据的确定性较低,95%置信区间(CI)与可能的获益和可能的危害一致(RR 1.20,95%CI 0.54 至 2.66;一项研究;36 名参与者)。我们没有发现任何关于无菌技术和清洁技术比较的不良事件风险或参与者满意度或偏好的数据。
一次性(无菌)导管与多次使用(清洁)导管:我们不确定一次性和多次使用导管在有症状的 UTI 风险方面是否有差异,因为证据的确定性较低,95%CI 与可能的获益和可能的危害一致(RR 0.98,95%CI 0.55 至 1.74;两项研究;97 名参与者)。一项比较一次性导管和多次使用导管的研究报告称,两组均无不良事件;对于这一比较,没有其他不良事件数据报告。我们没有发现任何关于参与者满意度或偏好的数据。
我们不确定亲水涂层导管与非涂层导管相比,在有症状的 UTI 人数方面是否有差异,因为证据的确定性较低,95%CI 与可能的获益和可能的危害一致(RR 0.89,95%CI 0.69 至 1.14;两项研究;98 名参与者)。与亲水涂层导管相比,非涂层导管可能略微降低尿道创伤和出血的风险(RR 1.37,95%CI 1.01 至 1.87;中等确定性证据)。如果亲水涂层导管与非涂层导管相比,对参与者满意度的影响(0-10 分量表上的 MD 为 0.7 分,95%CI 0.19 至 1.21;非常低确定性证据;一项研究;114 名参与者)存在不确定性。由于数据稀缺,我们无法评估亲水涂层导管与非涂层导管相比,在参与者偏好方面的证据确定性(一项交叉试验的 29 名参与者报告,更喜欢亲水涂层导管(19/29)而非非涂层导管(10/29))。
尽管有 23 项试验,但由于数据稀缺和证据的不确定性,仍然不清楚使用无菌或清洁技术、单次(无菌)或多次使用(清洁)导管、涂层或非涂层导管或不同导管长度是否会影响 UTI 或其他并发症的发生率。目前的研究证据不确定,设计和报告问题显著。需要进行更多设计良好的试验。此类试验应包括成本效益分析,因为不同导尿技术、策略和导管设计的使用可能会有很大差异。